FDA Approves Wegovy For Heart Conditions in Game-Changing Move : ScienceAlert

The US Food and Drug Administration has given the green light for a popular anti-obesity drug to be used to prevent serious heart conditions for the first time, in a move likely to expand insurance coverage.

Wegovy, produced by Danish pharmaceutical giant Novo Nordisk, was approved “to reduce the risk of cardiovascular death, heart attack and stroke in adults with cardiovascular disease and either obesity or overweight,” the FDA said in a statement.

The FDA’s decision could be a game changer for the approximately 70 percent of American adults who it says are either obese or overweight, by potentially expanding the pool of people eligible to have their insurance cover these expensive but effective injected medicines.

“This patient population has a higher risk of cardiovascular death, heart attack and stroke,” John Sharretts, the director of the FDA’s Division of Diabetes, Lipid Disorders and Obesity, said in a statement.

“Providing a treatment option that is proven to lower this cardiovascular risk is a major advance for public health,” he added.

Approval was based on a multinational trial involving 17,500 patients, with about half assigned the drug and the other half given a placebo. Both groups received standard medical care for the management of blood pressure and cholesterol, and both received healthy lifestyle counselling on diet and exercise.

The group that received Wegovy were 20 percent less likely to experience major cardiac events: death from cardiovascular causes, non-fatal heart attacks and non-fatal strokes.

While Wegovy has been approved since 2021 to treat obesity, many insurers do not cover it. Obesity Action Coalition, a patient advocacy organization, said they hoped the expansion of its use would remedy the situation.

Insurers “should have been providing coverage for anti-obesity medications prior to the announcement. Now, there should be no doubt that this treatment must be covered. Lives are at stake,” the group said.

The recent surge in popularity of anti-obesity drugs including Wegovy and Ozempic, which mimic a gut hormone to suppress appetite, has padded the profits of the companies that make them.

In fact, Novo Nordisk, which produces both Wegovy and Ozempic, has been so profitable that it has helped to keep the Danish economy afloat, according to Danske Bank.

The pharmaceutical giant’s success “is pushing overall activity levels up, while much of the rest of industry and housing construction have contracted,” Heidi Schauman, the bank’s global head of research, wrote in a note earlier this week.

Novo Nordisk’s head of development, Martin Holst Lange, welcomed the FDA’s announcement, calling it “an important milestone for people living with obesity and cardiovascular disease.”

Wegovy “has the potential to prolong lives by addressing some of the leading causes of preventable deaths by reducing the risks of cardiovascular events,” he said in a statement.

© Agence France-Presse